Stockert 3T Heater Cooler Systems
The FDA has updated the safety communication for the contamination potential of Mycobacterium chimeara associated with LivaNova PLC Stockert 3T Heater-Cooler Systems. The 3T system helps to control a patient’s body temperature during open-heart surgery. While the water in the system does not come into contact with the patient during normal usage, there is a potential risk for the Mycobacterium to become aerosolized through the systems exhaust vent. While generally not harmful to healthy people, the bacteria poses a serious risk for patients with weakened immune systems.
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Using our proprietary Passive M-TRAP® technology, we provide an easy method for collecting samples from the heater-cooler system. The Passive M-TRAP® attaches to the unit near the exhaust vent and will passively test the air passing through. This provides an easy setup with no additional pumps or power cords. It is recommended that the minimum sampling period is 10 hours of run time. However, since the Passive M-TRAP® cannot be overloaded, longer periods are encouraged. The cassette may be left in place for a week to 10 days of run time. A link to the sample protocol below goes through the details of collection.